The following data is part of a premarket notification filed by Electric Mobility Corp. with the FDA for Xlt, Rea Comfort, Spirea, Zoom.
| Device ID | K943936 |
| 510k Number | K943936 |
| Device Name: | XLT, REA COMFORT, SPIREA, ZOOM |
| Classification | Wheelchair, Mechanical |
| Applicant | ELECTRIC MOBILITY CORP. #1 MOBILITY PLAZA Sewell, NJ 08080 |
| Contact | Wayne R Hatley |
| Correspondent | Wayne R Hatley ELECTRIC MOBILITY CORP. #1 MOBILITY PLAZA Sewell, NJ 08080 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-12 |
| Decision Date | 1994-09-21 |